FDA’s proposed process for qualifying drug development tools allows for the convening of advisory committee meetings or other public discussions about complicated submissions involving proposed biomarkers or patient-reported outcome instruments. A Center for Drug Evaluation and Research draft guidance on qualification of drug development tools (DDTs) states CDER “may choose to hold public discussions” for complex or controversial programs.
According to Marc Walton, associate director of CDER’s Office of Translational Sciences, “We certainly envision that for some things a public workshop might be appropriate,” Walton said. “For other things a formal advisory committee might be appropriate. It’s conceivable there might be some other venues that might be suitable in some cases. I think we would very much choose the mechanism to best suit the individual case.”
DDTs that are qualified for a specific context of use will be made publicly available to any sponsor for that purpose, and CDER reviewers will not need to reconfirm the tool’s utility each time. A tool’s qualified context of use may be expanded through additional data submissions. Companies that are developing a DDT for their own proprietary use should submit the necessary information with their investigational new drug application, NDA or BLA, rather than using the qualification process outlined in the guidance.
The agency says it will consider qualifying other clinical trial outcome measurement tools developed to support labeling claims, such as clinician and caregiver rating scales.
The agency is developing a Manual of Policies and Procedures that will lay out all the internal steps involved in the qualification process and contain more concrete goals for timeframes.
DDT qualification is not an activity currently supported under the Prescription Drug User Fee Act. However, if FDA gets its way in the current round of PDUFA reauthorization negotiations, future user fee funds may help support the process.
Sounds like something worth paying for – if the FDA can deliver the goods.
